Health Condition 1: null- Asthma
Conditions
Interventions
Control Intervention1: Spirometry: Participants will attend an initial baseline visit for a range of tests including spirometry tests, blood tests and tests with the REDECOL investigational device.
Sponsors
Redecol Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged 18 to 80 years 2. Steroid naïve patients (not taken steroids for 28 days) 3. Patients presenting to the chest clinic 4. Patients able to read and understand the Patient Information Leaflet and Consent Form. 5. Patients able to provide deep inhaled breaths and exhale while holding a tube in their mouth. 6. Patients who will be available for subsequent diagnostic tests to be conducted within 30 days of the first visit to the chest clinic. 7. Patients with a normal Chest X-Ray
Exclusion criteria
Exclusion criteria: 1. Patients who have taken steroid medication in the previous 28 days. 2. Patients with chest infection or other known lung disease in the previous one month. 3. Patients who have taken a short-acting beta 2-agonists in the previous 8 hours, (before baseline test). 4.Patients who have taken Ipratropium bromide in the previous 24 hours, (before baseline test). 5.Patients with no clinically significant haematology, biochemistry or urinalysis results, (before baseline test). 6. Patients who have taken Long-acting beta 2-agonists in the previous 24 hours, (before baseline test). 7. Patients who have taken leukotriene antagonist in the previous 28 days, (before baseline test). 8. Patients who are too unwell to participate in this study e.g. emergency patients, (before baseline test). 9.Participants who, in the opinion of the Investigator, will not be able to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary performance measure will be the presence or absence of asthma, as identified by the test device and a chest physician using routine hospital diagnostic protocols along with spirometer to record Frequency of escape medication usage Spirometry â?? FEV1, FVC, FEF, PEF, MVV, SVC, TLC, FRC, RV, ERV Timepoint: 30 days of the first visit to the chest clinic | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoint will be the status based on presence or absence of other lung disease, as identified by the device and a chest physician using routine hospital diagnostic protocols.Timepoint: 30 days of the first visit to the chest clinic | — |
Countries
India
Contacts
Public ContactDr Prameela Rani
Clinsync clinical research Pvt. Ltd.
Outcome results
None listed